(64 days)
Not Found
No
The description focuses on digital image transport and archiving, replacing VCR-based systems. There is no mention of AI, ML, or advanced image processing beyond basic digital capture and storage.
No.
The device is a digital image capture, storage, and review system for echocardiography, replacing VCR-based systems. It does not provide any direct therapeutic action or treatment.
No
The device is described as an "image capture, storage, and review system." Its function is to replace VCR-based systems for transporting and archiving echocardiography images. It does not perform any analysis or interpretation of the images to diagnose medical conditions, nor does it mention image processing or AI/ML for diagnostic purposes. Its role is solely in managing the imaging data.
No
The device description explicitly states it provides a "high-speed digital link" between echo machines and VCR players, implying hardware components are involved in the image transport and archive solution, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "digital image capture, storage, and review system for echocardiography." This describes a system for managing medical images, not for performing tests on samples taken from the human body.
- Device Description: The description focuses on replacing VCR-based systems for image transport and archival. It deals with the handling of existing echocardiography images, not with analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly focused on the infrastructure and workflow for managing echocardiography images, which are generated by a separate diagnostic device (the echocardiograph).
N/A
Intended Use / Indications for Use
The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
A digital image capture, storage, and review system for echocardiography.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
The system includes an Image Acquisition Unit with JPEG compression up to 30:1, RGB, YC, or composite video input, and a Pentium II/Windows NT4.0 computer. User interface is via a multifunction remote control and mini-remote. The Review Station features internal hard disk and CD-R image storage media, 17", 19", or 21" color monitors up to 1024x1024 24 bit depth, and a Pentium II, 400 MHz/Windows NT 4.0 computer. User interface for the Review Station is keyboard, mouse, and rotary playback control. The Image Server uses CD-R or DLT tape media, with storage capacity up to 2 weeks of studies on-line, and approximately 1 year near-line. The system uses Fast Ethernet for networking and is DICOM compliant.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data: Not required for determination of substantial equivalence for this class of device.
Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980060 MPACS, LLC "EchoLINK"
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for Camtronics Medical Systems. The logo consists of a stylized "C" shape with three horizontal lines inside, followed by the text "Camtronics" in a bold, sans-serif font. Below "Camtronics" is the text "MEDICAL SYSTEMS" in a smaller font. The date "SEP 8 1999" is printed below the logo.
510(k) Summary
Date prepared: June 30, 1999 Name of contact person: Robert Kriedermann Device trade name: Echocardiography System Common name: Echocardiography System Classification name: Picture Archiving and Communications System Predicate substantially equivalent devices: K980060 MPACS, LLC "EchoLINK"
Device description and intended use: The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
Predicate device specifications comparison:
| | Principal Device | Predicate Device
MPACS "EchoLINK" K980060 |
|-------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------|
| | Camtronics
Echocardiography System | |
| Image Acquisition Unit | | |
| Compression type and
ratio | JPEG, up to 30:1 | MPEG2 up to 55:1 |
| Video source | RGB, YC, or composite input | S-Video or Composite, NTSC or
PAL |
| Computer/operating
system | Pentium II/Windows NT4.0 | Pentium II, 350 MH/Windows
NT4.0 |
| User interface | User multifunction remote
control, and mini-remote | Keypad and trackball |
| Review Station | | |
| Image storage media | Internal hard disk, CD-R | Internal hard disk, removable 3.5"
magneto-optical disk |
| Display | 17", 19", or 21" color monitors,
up to 1024x1024 24 bit depth | 21" color monitor, 1024x768, 24
bit color depth |
| Computer/operating
system | Pentium II, 400 MHz/windows
NT 4.0 | Pentium II, 350 MHz/Windows
NT4.0 |
| User interface | Keyboard, mouse, and rotary
playback control | Keyboard and mouse |
| Image Server | | |
| Media | CD-R, or DLT tape, or others
as available | 100 CD-R |
| Storage capacity | up to 2 weeks of studies on-
line, and approx 1 year near-
line | 20 minutes per CD-R at 4Mb/s
MPEG2 |
| Network | | |
| Type | Fast Ethernet | Fast Ethernet |
| DICOM | Yes | Yes |
1
Page 2 Camtronics Echocardiography System 510(k) Summary June 30, 1999
Performance data: Not required for determination of substantial equivalence for this class of device.
Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.
Substantial equivalence summary: The Camtronics Echocardiography System is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Camtronics Echocardiography System is the same as that of the predicate device "EchoLINK" marketed by MPACS, LLC. No new safety or effectiveness issues are raised with the Camtronics Echocardiography System. The subject device has substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses as a legally marketed predicate device.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 SEP
Robert Kriedermann Regulatory Specialist Camtronics, Ltd. 900 Walnut Ridge Drive P.O. Box 950 Hartland, Wisconsin 53029 Re:
K992259 Camtronics Echocardiography System Dated: June 30, 1999 Received: July 6, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Kriedermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head, represented by three curved lines.
3
l Page of
K992259 510(k) NUMBER (IF KNOWN) : Echocardiography System DEVICE NAME :
INDICATIONS FOR USE:
A digital image capture, storage, and review system for echocardiography.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮨﮯ (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
David A. Syzman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992259
Over-The-Counter-Use
(Optional Format 1-2-